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Multidisciplinary Care for Rheumatoid Arthritis (MAPPIT-RA Trial)

N/A

Waitlist Available

Led By George A Karpouzas, MD

Research Sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have at least moderate disease activity as indicated by a Clinical Disease Activity Index (CDAI) score >10 and Routine Assessment Patient Index Data (RAPID3) score >2

Be older than 18 years old

Must not have

Overlapping autoimmune or mixed connective tissue syndromes

Serious medical conditions, including chronic infection, advanced or decompensated heart failure, higher than class II chronic kidney disease, cancer (unless in remission for a period of 5 years or more), or any uncontrolled medical condition that is deemed by the investigators to interfere with the study protocol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 6 months, 9 months, 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new intervention for socioeconomically disadvantaged Hispanic adults with rheumatoid arthritis to see if it improves remission rates. The intervention is based on a partnership between the patient and the extended healthcare team, and includes things like self-management education and technology-based at-home monitoring of symptoms.

Who is the study for?

This trial is for socioeconomically disadvantaged Hispanic adults in the Greater Los Angeles area with moderate to severe rheumatoid arthritis (RA), as defined by specific clinical scores. Participants must be able to consent, follow the study schedule, and have a phone. Those with other autoimmune conditions, serious joint damage or medical issues that could interfere are excluded.

What is being tested?

The study tests a comprehensive RA treatment approach combining technology-based symptom monitoring at home, multidisciplinary care from healthcare professionals, nurse-led education and regular follow-ups against standard guideline-based care to see if it improves remission rates after 6 months.

What are the potential side effects?

Since this trial focuses on non-drug interventions like education and monitoring rather than medications, side effects may include discomfort or inconvenience related to frequent communication with healthcare providers and potential privacy concerns regarding symptom reporting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My disease is moderately active, with a CDAI score over 10 and a RAPID3 score over 2.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an autoimmune or mixed connective tissue condition.

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I do not have any serious medical conditions that could interfere with the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 6 months, 9 months, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months, 6 months, 9 months, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months, 9 months, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of participants achieving remission based on the Clinical Disease Activity Index at 6 months

Percentage of participants achieving remission based on the Routine Assessment Patient Index Data at 6 months

Secondary study objectives

Change in Fatigue Visual Analogue Scale (VAS) from baseline

Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) from baseline

Change in Pain Visual Analogue Scale (VAS) from baseline

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention ArmExperimental Treatment4 Interventions

In the multifaceted intervention, participants will first receive an educational session with monthly follow-up phone calls from a trained rheumatology nurse. A rheumatoid arthritis educational booklet will also be provided. During regularly scheduled clinic appointments (at baseline, 3 months, 6 months, 9 months, and 12 months), participants will receive multidisciplinary rheumatologic care, including evaluation by a rheumatologist, physical therapist and psychologist. In addition, participants will be scheduled for ad hoc rheumatology appointments if technology-based symptom monitoring and reporting indicates a marked increase in RA disease activity.

Group II: Control ArmActive Control2 Interventions

Participants will receive standard of care treatment from their assigned rheumatologists during routine clinic appointments scheduled quarterly for the 12-month trial duration. Referrals to ancillary services will occur in a standard of care fashion. Participants will additionally receive monthly healthcare coordinator calls and be given the rheumatoid arthritis educational booklet.

0 / 3Eligibility criteria met